Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-17

Study Completion Date

2027-08-01

Brief Summary

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The main purpose of research is to examine and understanding the development of hypertension in obese adults with insulin resistance. Findings from our studies will identify unique mechanisms that can be targeted to limit increases in vascular dysfunction and reduce the excessively high prevalence of hypertension and risk for cardiovascular disease (CVD).

This study is testing the health of the blood vessels and the activity of the nerves that control the blood vessels in adults with insulin resistance. The extent to which ascorbic acid (Vitamin C) improves the function of the blood vessels will be determined. The primary outcome is blood pressure, which is the result of blood vessel health and activity of the nerves, and the reduction in blood pressure that is observed with ascorbic acid.

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Detailed Description

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Conditions

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Hypertension Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo infusion

Saline will be administered over 2 hours

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Placebo (saline) will be administered

Ascorbic acid infusion

Ascorbic acid solution (American Regent Laboratories Inc.) will be obtained from the KU Investigational Pharmacy located in the University of Kansas (KU) Clinical Research Center where studies will take place. A priming bolus of 0.06 g ascorbic acid/kg fat free mass (FFM) dissolved in 100 mL of saline will be infused intravenously at 5 mL/min for 20 minutes, followed immediately by a "drip-infusion" of 0.02 g/kg FFM dissolved in 30 mL of saline administered over 2 hours at 0.5 mL/min.

Group Type ACTIVE_COMPARATOR

Ascorbic acid solution (American Regent Laboratories Inc.)

Intervention Type DRUG

Ascorbic acid solution (American Regent Laboratories Inc.) will be obtained from the KU Investigational Pharmacy located in the KU Clinical Research Center where studies will take place. A priming bolus of 0.06 g ascorbic acid/kg fat free mass (FFM) dissolved in 100 mL of saline will be infused intravenously at 5 mL/min for 20 minutes, followed immediately by a "drip-infusion" of 0.02 g/kg FFM dissolved in 30 mL of saline administered over 2 hours at 0.5 mL/min.

Interventions

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Ascorbic acid solution (American Regent Laboratories Inc.)

Ascorbic acid solution (American Regent Laboratories Inc.) will be obtained from the KU Investigational Pharmacy located in the KU Clinical Research Center where studies will take place. A priming bolus of 0.06 g ascorbic acid/kg fat free mass (FFM) dissolved in 100 mL of saline will be infused intravenously at 5 mL/min for 20 minutes, followed immediately by a "drip-infusion" of 0.02 g/kg FFM dissolved in 30 mL of saline administered over 2 hours at 0.5 mL/min.

Intervention Type DRUG

Saline

Placebo (saline) will be administered

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Obese: BMI \>30 m/kg2
2. Middle-aged: 35-65 years
3. Participants must be willing and able to discontinue taking any vitamin C or E supplements or omega-3 fatty acids beginning 2 weeks prior.
4. Able and willing to provide written informed consent

Exclusion Criteria

1. Diabetes mellitus: fasting glucose \< 1267 mg/dL and/or HbA1c \< 6.5%
2. Currently taking a statin or antihypertension medication
3. Hyperlipidemia: Fasting triglycerides \< 250 mg/dL
4. Hypertension: \<130/80 mmHg
5. History of heart disease (e.g., myocardial infarction, stent)
6. History of vascular disease (e.g., bypass, stroke)

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No